Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122884422 | 12288442 | 2 | F | 20141122 | 20160629 | 20160420 | 20160705 | EXP | US-BIOGEN-2014BI048597 | BIOGEN | 26.01 | YR | F | Y | 0.00000 | 20160705 | MD | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122884422 | 12288442 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | P80032 | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 122884422 | 12288442 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | P80032 | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 122884422 | 12288442 | 3 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | P80032 | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 122884422 | 12288442 | 4 | SS | TYSABRI | NATALIZUMAB | 1 | Unknown | P80032 | 125104 | UNKNOWN | |||||||||
| 122884422 | 12288442 | 5 | C | CALCIUM | CALCIUM | 1 | Oral | 0 | 500 | MG | PREPARATION FOR ORAL USE(NOS) | QD | |||||||
| 122884422 | 12288442 | 6 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 122884422 | 12288442 | 7 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 0 | 2000 | IU | PREPARATION FOR ORAL USE(NOS) | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122884422 | 12288442 | 1 | Multiple sclerosis |
| 122884422 | 12288442 | 5 | Product used for unknown indication |
| 122884422 | 12288442 | 6 | Product used for unknown indication |
| 122884422 | 12288442 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122884422 | 12288442 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122884422 | 12288442 | Maternal exposure during pregnancy | |
| 122884422 | 12288442 | Multiple sclerosis relapse |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 122884422 | 12288442 | 1 | 20070720 | 20090213 | 0 | |
| 122884422 | 12288442 | 2 | 20091030 | 20140416 | 0 | |
| 122884422 | 12288442 | 3 | 20141128 | 20150817 | 0 | |
| 122884422 | 12288442 | 4 | 20160408 | 20160408 | 0 |